Spots Global Cancer Trial Database for NC-6004 With 5-FU and Cetuximab for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: NC-6004 With 5-FU and Cetuximab for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Official Title: Phase I/II Clinical Trial of NC-6004 in Combination With 5-FU and Cetuximab as First-line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Study ID: NCT03109158
Study Description
Brief Summary: Part 1 of this study will establish a recommended Phase II (RPII) dose for the triplet combination of NC-6004 plus 5-Fluorouracil (5-FU) and cetuximab. Part 2 will provide the efficacy signal of the triplet combination in this patient population.
Detailed Description: NC-6004 is a polymeric micelle-containing cisplatin as an active moiety. The nanoparticle provides sustained release of the active moiety and utilizes the enhanced permeability and retention effect to target release of platinum to tumors. Currently available nonclinical data and enhanced pharmacokinetics suggest that NC-6004 has the potential to be more active than cisplatin, with increased tolerability.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cedars Sinai Medical Center, Los Angeles, California, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Center, Detroit, Michigan, United States
Intermountain Precision Genomics, Billings, Montana, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Complex Oncology Center - Shumen EOOD, Shumen, , Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD, Sofia, , Bulgaria
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza, , Hungary
Pecsi Tudomanyegyetem, Pécs, , Hungary
Tolna Megyei Balassa Janos Korhaz, Szekszárd, , Hungary
Coltea Clinical Hospital, Bucharest, , Romania
Prof Dr I Chiricuta Institute of Oncology, Cluj-Napoca, , Romania
Oncology Center Sfantul Nectarie, Craiova, , Romania
Euroclinic Oncology Center SRL, Iaşi, , Romania
Institutul Regional de Oncologie Iasi, Iaşi, , Romania
Contact Details
Name: Atsushi Osada, Study Director
Affiliation: NanoCarrier Co., Ltd.
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
